An Evaluation Of Healthy Ankle Motion And Morphology

• ClinicalTrials.gov Identifier: NCT03619382
• Recruitment Status: Unknown
• First Posted: August 7, 2018
• Last Update Posted: March 20, 2019
• Sponsor: Paragon 28
• Collaborator: Focus Medical Design and Development
• Information provided by (Responsible Party): Paragon 28

Tracking Information

• First Submitted Date: July 11, 2018
• First Posted Date: August 7, 2018
• Last Update Posted Date: March 20, 2019
• Actual Study Start Date: July 16, 2018
• Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 6, 2018)

Relative rotations of bones [ Time Frame: 1 day ]

Determine relative tri-axial rotations between bones of the foot and ankle using reconstructed 3-dimensional computer models. All rotations will be measured in degrees (°).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 6, 2018)

• Relative translations of bones [ Time Frame: 1 day ]
  Determine relative multi-directional translation between bones of the foot and ankle using reconstructed 3-dimensional computer models. All translations will be measured in mm.
• Morphology - size and shape of the bones of the foot and ankle [ Time Frame: 1 day ]
  Evaluate the size and shape of the bones of the foot and ankle using reconstructed 3-dimensional computer models relative to height, weight, body mass index and gender. All distances will be measured in mm.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Evaluation Of Healthy Ankle Motion And Morphology
• Official Title: An Evaluation Of Healthy Ankle Motion And Morphology In Different Phases Of Simulated Gait Using A Weight-bearing CBCT Scan
• Brief Summary: Determine motion and morphology of the healthy ankle during simulated gait.
• Detailed Description: Healthy volunteers will undergo weight-bearing, cone beam CT scans of their foot/ankle during 3 phases of simulated gait. Motion and morphology of the foot and ankle will be quantified and analyzed.
• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Volunteers who have a healthy ankle
• Condition: Healthy Ankle

Intervention

• Radiation: Cone Beam Computed Tomography
  Computer tomography (CT) of the foot/ankle for determination of motion and morphology
• Radiation: Radiographs
  Standard radiographs of the foot/ankle as part of the screening criteria

Study Groups/Cohorts

Healthy

Subjects identified to have a healthy foot/ankle

Interventions:

• Radiation: Cone Beam Computed Tomography
• Radiation: Radiographs

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: August 20, 2018): 19
• Original Estimated Enrollment (submitted: August 6, 2018): 25
• Estimated Study Completion Date: December 31, 2019
• Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. The subject self-reports having a right healthy ankle.
2. The subject agrees to comply with the requirements of the study and complete the study measures.
3. The subject is between the ages of 18 and 65.
4. The subject is willing to provided written informed consent.

Exclusion Criteria:

1. The subject is pregnant.
2. The subject reports having been diagnosed with any form of diabetes.
3. The subject reports having surgery on the right foot, right ankle and/or right knee.
4. The subject reports a history of repeated ankle sprains or injuries to the right ankle.
5. The subject reports a history of instability of the right ankle.
6. The subject reports chronic or recurring pain of the right ankle.
7. The subject is: a prisoner, unable to understand what participation in the study entails, mentally incompetent, and/or known abuser of alcohol and/or drugs.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03619382
• Other Study ID Numbers: P10-SP-0001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Paragon 28
• Study Sponsor: Paragon 28
• Collaborators: Focus Medical Design and Development

Investigators

• Principal Investigator: James Clancy, DPM; Orthopedic Center of Palm Beach County

• PRS Account: Paragon 28
• Verification Date: March 2019